Analysis   Items

Specfications

Analysis   Results

1.

Characteristics

White or almost white crystals or crystalline powder

White crystalline powder

2.

Identification

Positive

Positive

3.

Clarity of Solution

Clear

Clear

4.

Co lour of Solution

≤BY7

< BY7

5.

Melting point

191°C-192°C

191°C

6.

Assay

99.0%-100.0%

99.7%

7.

Acidity(PH)

2.2-2.5

2.32

8.

Residue on Ignition

≤0.1%

0.01%

9.

Specific Rotation

+20.5°C-+21.5°C

+21.40°C

10.

Heavy Metals

≤0.0003%

<0.0003%

11.

Oxalic Acid

≤0.2%

<0.2%

12.

Copper

≤0.0005%

<0.0005%

13.

Iron

≤0.0002%

<0.0002%

14.

Lead

≤2ppm

<2ppm

15.

Organic Volatile Impurities

Meets USP 29 stipulation

Meets the requirements